ELECTROMAGNETIC VASCULAR FLOW SENSOR AND MEASUREMENT TECHNIQUE
A stent system can be used to measure a flow characteristic of a fluid, such as a biomagnetic fluid, flowing through a passage of a support structure forming a portion of the stent system. The stent system can include a magnetic apparatus mechanically coupled to the support structure, the magnetic apparatus configured to generate a magnetic field through the passage, the field including a component perpendicular to a direction of flow of the biological fluid. The stent system can include electrodes mechanically coupled to the support structure, where the electrodes are connected to output a potential difference generated by the flow of the biological fluid through the magnetic field indicative of a velocity of flow of the biological fluid through the passage.
This patent application claims the benefit of priority of Arka Das et al., U.S. Provisional Patent Application Ser. No. 63/352,153, titled “ELECTROMAGNETIC VASCULAR FLOW SENSOR,” filed on Jun. 14, 2022 (Attorney Docket No. 4568.008PRV), which is hereby incorporated by reference herein in its entirety.
TECHNICAL FIELDThis document pertains generally, but not by way of limitation, to stent structures, and more particularly to electromagnetic flow sensors for intravascular or extravascular stent structures, such as can be communicatively coupled or otherwise associated with another extravascular element, such as comprising excitation or measurement circuitry.
BACKGROUNDCoronary artery disease (CAD) is the number one cause of death in the United States for both men and women. It is estimated that 13 million Americans have CAD and that 350,000 die from it each year. Metal stents can be employed along with balloon angioplasty (PTCA) to treat CAD and open narrowed coronary arteries. To reduce the risk of restenosis, the stents may be coated with therapeutic agents that are released locally. These drug-eluting stents (DES) can reduce the risk of restenosis from 20% with the use of bare metal stents to less than 5%.
SUMMARY OF THE DISCLOSURELate stent thrombosis (LST), caused by a blood clot completely occluding flow through the stent, is a condition that usually requires urgent revascularization. The present inventors have recognized that a flow of a biomagnetic fluid, such as blood flow, can be measured using a stent with an electromagnetic flow sensor, such as to noninvasively detect reduced blood flow through the stent due to restenosis or thrombosis. The stent can be intravascular, such as located within a body lumen such as within an artery or vein, or the stent can be placed in an extravascular location such as encircling a structure in which a body fluid such as blood is flowing. Such a flow sensor can use Faraday's law of induction to measure blood flow. The flow sensor described herein can be used as a portion of a percutaneously delivered system (e.g., such as including a stent structure for delivery to an intravascular or extravascular location according to various examples), such as forming a portion an active implanted flow sensor, an in-situ blood analysis or separation system such as based on erythrocyte transport, or a thrombus detector, as illustrative examples.
In an example, a stent system can include a support structure defining a passage through which a biological fluid is to flow, a magnetic apparatus mechanically coupled to the support structure, the magnetic apparatus configured to generate a magnetic field through the passage, the field including a component perpendicular to a direction of flow of the biological fluid, and electrodes mechanically coupled to the support structure, the electrodes connected to output a potential difference generated by the flow of the biological fluid through the magnetic field indicative of a velocity of flow of the biological fluid through the passage. In another example, a method for measuring a flow of a biological fluid can include, within a passage defined by a stent support structure, establishing a magnetic field oriented in a first direction perpendicular to a flow direction of a biological fluid, using electrodes mechanically coupled to the stent support structure, measuring a potential across a region where the biological fluid flows, elicited by the magnetic field, and determining a velocity of the flow of the biological fluid using the potential. In the examples mentioned above, the magnetic field can be established using a permanent magnet (or multiple such magnets), an electromagnet (or multiple such magnets) or a combination of permanent magnet and electromagnetic elements.
This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
As mentioned above, a flow of a biomagnetic fluid, such as blood flow, can be measured using a stent with an electromagnetic flow sensor, such as to noninvasively detect reduced blood flow through the stent due to restenosis or thrombosis. The stent can be intravascular, such as located within a body lumen such as within an artery or vein, or the stent can be placed in an extravascular location such as encircling a structure in which a body fluid such as blood is flowing. Such a flow sensor can use Faraday's law of induction to measure blood flow. The flow sensor may be manufactured by laser cutting and Direct Metal Laser Sintering (DMLS), as examples. Two illustrative examples are described herein. Example I (e.g.,
A biomagnetic fluid may be present in living organisms and its flow is influenced by the presence of a magnetic field. An example of a biomagnetic fluid is blood, which behaves as a magnetically conductive fluid, due to its complex interaction of the intercellular protein, cell membrane, and the hemoglobin, a form of iron oxide, which is present at a uniquely high concentration in the mature erythrocytes. Magnetic properties of blood are affected by factors such as a state of oxygenation. The electrodes 106A and 106B can be used measure a potential created by the blood flowing through the stent passage 102 based on a Lorentz force. The Lorentz force is the combination of electric and magnetic force acting on a point charge under an applied electromagnetic field. The force experienced by a particle of charge q moving with a velocity v under an applied electric field E and a magnetic field B is F=q(E+v×B).
Variation of this Lorentz force leads to the principle of Faraday's law of Induction. The electromagnetic flow sensor 100 works according to Faraday's law of induction. To measure a flow rate, the stent passage 102 is located in the magnetic field (B). Blood moving with velocity (V) that flows through the stent passage 102 in a direction orthogonal to the applied magnetic field induces an electromotive force in terms of potential difference (U) proportional to the mean flow velocity, which can establish a corresponding voltage across the electrodes 106A and 106B. The potential difference (U) can be monitored by electronic components 112 to identify a flow rate for the blood flowing through the stent passage 102.
The electronic components 112 may include one or more components capable of detecting or otherwise acting upon the potential difference between the electrodes 106A and 106B. For example, the electronic components 112 may include a transmitter circuit capable of conditioning and wirelessly transmitting a signal indicative of the potential difference between the electrodes 106A and 106B such that one or more remote systems may receive data indicative of the value to identify a flow rate of the blood through the stent passage 102. In another example, the electronic components 112 may include an analog circuit, digital circuit, or mixed signal circuitry comprising analog and digital circuits. As examples, the electronic components 112 can include data storage circuits or devices, switches, relays, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), or any other components. For example, the electronic components 112 may include an ASIC capable of interpreting the potential difference between the electrodes 106A and 106B to detect a decrease in blood flow, in response to which an indicator may be transmitted or otherwise output to provide an indication of a decrease in blood flow to one or more remote users or systems.
The examples of
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- Cluster 1: (E1, E2): Pair of electrodes and (M1, M2) pair of permanent magnets
- Cluster 2: (E3, E4): Pair of electrodes and (M3, M4) pair of permanent magnets
- Cluster 3: (E5, E6): Pair of electrodes and (M5, M6) pair of permanent magnets
When a conductive fluid flows through the stent with a velocity V, with a magnetic field B acting perpendicular to the flow from top to bottom (as oriented in the illustrative example of
For examples having conductive interconnections (e.g., wires or leads), the electrode cluster assembly may be connected in a manner establishing a negative-positive-negative (NPN) configuration or a positive-negative-positive (PNP) configuration, using a pull-up element (e.g., a resistor) to output a square wave signal with varying frequency proportional to the flow rate of the conductive fluid flowing through the tube. As an illustration, nodes 1 and 3 can be connected to respective electrodes in an electrode pay (e.g., E1 and E2). Nodes 2 and 4 can be connected to each other using a switch structure (e.g., a solid-state switch such as using a transistor network). For example, such a switch can be energized by an excitation source (e.g., an external AC source or an AC source included as a portion of implantable circuit), such as toggling between open and closed states. Such toggling can provide a time-varying voltage representative of the flow characteristic, +UB. The time-varying voltage representative of the flow characteristic can be processed, such as using a signal processing topology (e.g., “signal chain”) as shown illustratively in the example of
Aspects of the example (e.g., “Example I”) of
In this example, rather than the permanent magnet clusters of Example I (e.g.,
Aspects of the configuration of Example II (e.g.,
Each of the non-limiting aspects in this document can stand on its own or can be combined in various permutations or combinations with one or more of the other aspects or other subject matter described in this document.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to generally as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc., are used merely as labels, and are not intended to impose numerical requirements on their objects.
Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Such instructions can be read and executed by one or more processors to enable performance of operations comprising a method, for example. The instructions are in any suitable form, such as but not limited to source code, compiled code, interpreted code, executable code, static code, dynamic code, and the like. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
1. A stent system, comprising:
- a support structure defining a passage through which a biological fluid is to flow;
- a magnetic apparatus mechanically coupled to the support structure, the magnetic apparatus configured to generate a magnetic field through the passage, the field including a component perpendicular to a direction of flow of the biological fluid; and
- electrodes mechanically coupled to the support structure, the electrodes connected to output a potential difference generated by the flow of the biological fluid through the magnetic field indicative of a velocity of flow of the biological fluid through the passage.
2. The stent system of claim 1, wherein the magnetic apparatus comprises a permanent magnet structure.
3. The stent system of claim 2, wherein the permanent magnet structure comprise a first permanent magnet positioned at a first radial position on a perimeter of the passage, and a second permanent magnet positioned at a second radial position on the perimeter of the passage opposite the first position.
4. The stent system of claim 3, wherein the electrodes comprise a first electrode positioned at a third radial position on the perimeter of the passage between the first and the second permanent magnets, and a second electrode positioned at a fourth radial position on the perimeter of the passage opposite the third position.
5. The stent system of claim 1, wherein the magnetic apparatus comprises an electromagnet structure comprising one or more coils excited to generate the magnetic field.
6. The stent system of claim 5, wherein the electromagnet structure comprises a first electromagnet positioned at a first radial position on a perimeter of the passage, and a second electromagnet positioned at a second radial position on the perimeter of the passage opposite the first position.
7. The stent system of claim 6, wherein the electrodes comprise a first electrode positioned at a third radial position on the perimeter of the passage between the first and the second electromagnets, and a second electrode positioned at a fourth radial position on the perimeter of the passage opposite the third position.
8. The stent system of claim 1, wherein the support structure is configured for delivery to an extravascular location.
9. The stent system of claim 8, wherein the support structure is at least one of expandable or collapsible.
10. The stent system of claim 1, wherein the support structure is configured for delivery to an intravascular location.
11. The stent system of claim 10, wherein the support structure is expandable after delivery to an intravascular location.
12. A method for measuring a flow of a biological fluid, the method comprising:
- within a passage defined by a stent support structure, establishing a magnetic field oriented in a first direction perpendicular to a flow direction of a biological fluid;
- using electrodes mechanically coupled to the stent support structure, measuring a potential across a region where the biological fluid flows, elicited by the magnetic field; and
- determining a velocity of the flow of the biological fluid using the potential.
13. The method of claim 12, wherein the electrodes are located at respective radial positions along the stent support structure that are offset by ninety degrees from corresponding radial positions of magnets used to establish the magnetic field.
14. The method of claim 13, wherein the magnets comprise permanent magnets.
15. The method of claim 13, wherein the magnets comprise electromagnet structures.
16. The method of claim 15, wherein establishing the magnetic field comprises exciting the electromagnet structures using an alternating current waveform.
17. The method of claim 16, wherein establishing the magnetic field comprises selecting at least one of an amplitude or a frequency of an excitation waveform to elicit a measurable potential for the electrodes.
18. The method of claim 13, comprising deploying the stent support structure at an extravascular location.
19. The method of claim 13, comprising deploying the stent support structure at an intravascular location.
20. A method for measuring a flow of a biological fluid, the method comprising:
- within a passage defined by a stent support structure, a means for establishing a magnetic field oriented in a first direction perpendicular to a flow direction of a biological fluid;
- a means for measuring a potential across a region where the biological fluid flows, elicited by the magnetic field; and
- a means for determining a velocity of the flow of the biological fluid using the potential.
Type: Application
Filed: Jun 14, 2023
Publication Date: Dec 14, 2023
Inventors: Arka Das (Daytona Beach, FL), Eduardo Divo (Daytona Beach, FL), Anthony Nunez (Kissmmee, FL)
Application Number: 18/334,759